Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871999
• Other study ID #: LCKY2016-39
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or cell biology. Patients are randomized into 2 groups: The control group receive normal treatment only, the experimental group receive acupuncture therapy besides normal treatment. Clinical evaluation is based on the observation of the pain degree and life quality improvement. Blood biochemistry tests mainly include Prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male) etc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. General anesthesia,Gastric and Colorectal Cancer surgery under Laparoscopic;

2. Pathology diagnosed;

3. Brain, heart, lung, liver, kidney are at good condition before surgery;

4. No mental disorder, no conscious obstacle, no limbs disability.

Exclusion Criteria:

1. Severely complication after surgery;

2. Contraindication of the acupuncture;

3. Patients with mental disease;

4. Patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.

Related Conditions & MeSH terms

• Carcinoma
• Gastrointestinal Carcinoma
• Pain

Intervention

Device:
• Acupuncture therapy

Procedure:
• Laparoscopic Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaonan Cui

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain degree change after surgery, Graded according to Numerical Rating Scale(NRS)		day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Secondary	Assessing the quality of life(QOL) change in 4 grades and recording: appetite, mental state, sleep, fatigue, attitude towards treatment, daily life ability		day 1, day 2, day 3, day 4, day 5, day 6, day 7 after surgery
Secondary	Prostaglandin E2(PGE2) in blood		day 2,day 7 after surgery
Secondary	Estradiol(Female) in blood		day 2, day 7 after surgery
Secondary	Th1/Th2 in blood		day 2, day 7 after surgery
Secondary	5-Hydroxytryptamine(5-HT) in blood		day 2,day 7 after surgery
Secondary	Histamine(HIS) in blood		day 2,day 7 after surgery
Secondary	Th17/Treg in blood		day 2, day 7 after surgery
Secondary	Testosterone(Male) in blood		day 2,day 7 after surgery